FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES

Tampon, Menstrual, Unscented

FIRST QUALITY HYGIENIC, INC.

The following data is part of a premarket notification filed by First Quality Hygienic, Inc. with the FDA for Femtex Tampons And Other Private Label Plastic Applicator Tampons; Consumer Packages And Bulk Packages.

Pre-market Notification Details

• Device ID: K023479
• 510k Number: K023479
• Device Name: FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES
• Classification: Tampon, Menstrual, Unscented
• Applicant: FIRST QUALITY HYGIENIC, INC. 73 FRANKLIN TURNPIKE Allendale, NJ 07401
• Contact: Robert J Staab
• Correspondent: Robert J Staab; FIRST QUALITY HYGIENIC, INC. 73 FRANKLIN TURNPIKE Allendale, NJ 07401
• Product Code: HEB
• CFR Regulation Number: 884.5470 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-10-17
• Decision Date: 2002-11-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
40024291290436	K023479	000
00024291290438	K023479	000
10024291290435	K023479	000